In July 2012, the FDA approved Qsymia, which is considered to be the most effective of the weight loss medications considered by the FDA in recent years.
Here is the official FDA announcement of Qsymia.
Qsymia was previously known as Qnexa but Vivus was asked by the FDA to change the name to avoid confusion with other medication.
Qsymia is a combination of the appetite suppressant phentermine (the safe half of the diet drug Fen-Phen) and the anti-seizure/migraine medication, Topiramate Extended-Release.
Qsymia is recommended for obese adults (BMI>30) or for overweight adults who have an additional complication (type 2 diabetes, high blood pressure, etc.)
Qsymia is not a "miracle" new diet pill. If you want to see real results, you will need to follow a reduced-calorie diet and increase your physical activity. By the way, this is recommended for all diet pills currently on the market, no exception.
No study has been done to see the effect of Qsymia with other dietary supplements, so if your doctor prescribes you Qsymia, follow his dosage indications.
Qsymia has not been tested (and approved) for patients under 18 years old (17% of children in the USA are obese).
Qsymia is pronounced cue-SIM-ee-uh.
Qsymia™ is a 'combo' medication made of 2 main ingredients:
Phentermine is the well-known appetite suppressant and main active ingredient of Qsymia™
Topiramate, also known under the trademark Topamax, was originaly prescribed as an anticonvulsant and migraine medication. It can aid in weight loss by increasing the feeling of being full, making foods taste less appealing and increasing calorie expenditure.
On Sep 18, 2012, Vivus announced the availability of Qsymia™ in the USA. The product is not yet approved outside the USA.
Qsymia™ is only available by mail order through certified pharmacies in the Qsymia Home Delivery Network.
What are the limitations?
It is composed of the following Certified Pharmacies:
So this means that you will not be able to get Qsymia from your local pharmacy if it is not part of the Qsymia Home Delivery Network.
If you are a retail pharmacist and receive a prescription for Qsymia™, you must redirect the patient to a certified pharmacy.
Qsymia Prescribing Information
A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks.
The FDA has required a REMS for Qsymia.
The purpose of the Qsymia REMS is to inform prescribers and females of reproductive potential about:
Vivus, the manufacturer of Qsymia™ has prepared a Healthcare Provider Training Program (pdf).
Qsymia exists in capsules in 4 different dosage forms.
Strength: phentermine hydrochloride 3.75 mg (base) / topiramate extended-release 23 mg
Imprint: VIVUS 3.75/23
Strength: phentermine hydrochloride 7.5 mg (base) / topiramate extended-release 46 mg
Imprint: VIVUS 7.5/46
Color: Purple / Yellow
Strength: phentermine hydrochloride 11.25 mg (base) / topiramate extended-release 69 mg
Imprint: VIVUS 11.25/69
Strength: phentermine hydrochloride 15 mg (base) / topiramate extended-release 92 mg
Imprint: VIVUS 15/92
Color: Yellow / White
If after 12 weeks on Qsymia 7.5 mg/46 mg, 3% of weight loss is not reached, discontinue or increase dose.
If after 12 weeks on Qsymia 15 mg/92 mg, which is the maximum daily dose, 5% of weight loss is not reached, discontinue.
To avoid possible seizure, discontinue Qsymia 15 mg/92 mg gradually.
For patients with kidney impairment or moderate hepatic impairment, Qsymia 7.5 mg/46 mg is recommended.
Qsymia is manufactured by:
1172 Castro Street
Mountain View, CA 94040
Phone:1 (888) 998-4887
We detected that you are using a Spanish browser.
Would you like to switch the language?Sí, cambiar a Español